Osseointegration,
a process which attaches a prosthetic limb directly to the skeleton, can be an
alternative option to traditional socket-based prosthetics for qualified
patients. It is currently undergoing clinical trials at WalterReedNationalMilitaryMedicalCenter in Bethesda, Maryland.
(U.S. Navy photo by Mass Communication Specialist 2nd Class Joshua D. Sheppard)

Experts across the Military Health
System are collaborating with civilian researchers on an advanced alternative
to socket-based prosthetics for some amputees. Osseointegration, a process that
attaches the prosthesis directly to the skeleton, can improve comfort and
mobility for qualified patients with amputations.

Navy Cmdr. (Dr.) Jonathan A.
Forsberg, an orthopedic oncologist at WalterReedNationalMilitaryMedicalCenter in Bethesda,
Maryland, and an investigator at the NavalMedicalResearchCenter,
said he treats patients who are newly injured and those who have been living
with amputations for many years.

“Developing osseointegration as a
capability within the Department of Defense makes good on our commitment to
provide world-class solutions for combat casualties throughout the entire
spectrum of care,” said Forsberg. Although clinical trials for osseointegration
have been performed elsewhere around the world, the clinical trial at Walter
Reed is the first of its kind to be performed in the United States.

The
initial surgery for osseointegration attaches a fixture or implant onto or
within the bone, and the bone takes about three months to grow into the
implant. The second surgery prepares the soft tissue for an attachment, called
an abutment, which protrudes through the skin. Similar to the way a dental
implant is secured to the jaw bone, a prosthetic limb is attached directly to
the abutment. (Courtesy graphic)

The Osseointegration Program within
the Uniformed Services University of Health Sciences-Walter Reed Department of
Surgery, is headed by Forsberg and Army Lt. Col. (Dr.) Benjamin Kyle Potter,
chief of orthopedics at Walter Reed. They hope to improve function and quality
of life while minimizing risk for these wounded warriors who have suffered
visible and devastating injuries, said Potter.

“We’re unique here at Walter Reed and
San Antonio
within the military system to have these amputee centers of excellence,” said
Potter. “This is one of several technologies that are here, or on the near
horizon, and have the potential to dramatically improve the outcomes following
amputation.”

A four-year Food and Drug
Administration clinical trial began in October using the Osseointegration
Prosthesis for the Rehabilitation of Amputees (OPRA) – one of two implants
currently available. At the moment, the study involves patients with
transhumeral, or above elbow, amputations. However, Walter Reed is also looking
at transfemoral, or above knee, amputees, said Potter.

"Traditional socket-based
prosthesis rely on soft tissue to transfer the weight of the load from the
ground to the skeleton,” said Forsberg. “Osseointegration eliminates the need
for soft tissue attachment.”

The initial surgery for
osseointegration attaches a fixture or implant onto or within the bone, and the
bone takes about three months to grow into the implant. The second surgery
prepares the soft tissue for an attachment, called an abutment, which protrudes
through the skin. Similar to the way a dental implant is secured to the jaw
bone, a prosthetic limb is attached directly to the abutment. Over the next six
months, the patient progressively transfers force to the skeleton in a controlled
manner so that no loosening of any part occurs.Earlier this year, the program’s
first patient, former Marine Sgt. Michael Frazier, received another type of
osseointegrated implant from Potter and Forsberg: the DoD-funded Compress®
Transdermal Implant. In May 2011, Frazier stepped on an improvised explosive
device in Trek Nawa, Afghanistan,
losing both legs to the blast.

"Being in a wheelchair 24/7
started to take a toll on my mind and body, so I needed a change, to get up and
walk again,” said Frazier, who medically retired in December 2012. He was
walking around in about a month after the procedure, and felt more comfortable
and confident, he said. “[The leg is] easier to put on and you have so much
more control and feeling because it’s pretty much a part of your body.”

Many institutions are collaborating
with Walter Reed’s osseointegration program, including the Office of Naval
Research, UniformedServicesUniversity
of the Health Sciences, University of California - San
Francisco, and several other universities.

"By centralizing
osseointegration at one DoD institution, which is at Walter Reed right now, we
are able to standardize certain processes – patient selection, evaluation,
surgery, rehabilitation – before pushing it out to the rest of the DoD
community,” said Forsberg.

Dr.
Justin Sanchez, director of the Defense Advanced Research Projects Agency’s
Biological Technologies Office, fist-bumps with one of the first two advanced
“LUKE” arms to be delivered from a new production line during a ceremony at WalterReedNationalMilitaryMedicalCenter
in Bethesda, Maryland. (DoD photo)

WASHINGTON — The Defense
Advanced Research Projects Agency is making available to military amputees the
first production versions of a groundbreaking upper-limb prosthesis, according
to a DARPA press release.

Dr. Justin Sanchez, director of
DARPA’s Biological Technologies Office, delivered the first two advanced “LUKE”
arms from a new production line during a ceremony yesterday – evidence that the
fast-track DARPA research effort has completed its transition into a commercial
enterprise, DARPA officials said.

The ceremony took place at WalterReedNationalMilitaryMedicalCenter
in Bethesda, Maryland.

“The commercial production and
availability of these remarkable arms for patients marks a major milestone in
the [DARPA] Revolutionizing Prosthetics program and most importantly an
opportunity for our wounded warriors to enjoy a major enhancement in their
quality of life,” Sanchez said, “and we are not stopping here.”

The RP program is supporting initial
production of the bionic arms and is making progress restoring upper-arm
control, he added.

As part of the production transition
process, DARPA is collaborating with Walter Reed to make the bionic arms
available to service members and veterans who are rehabilitating after
suffering upper-limb loss, DARPA says.

LUKE stands for “life under kinetic
evolution” but is also a passing reference to the limb that Luke Skywalker wore
in Star Wars: Episode V, The Empire Strikes Back.

The limbs are being manufactured by
Mobius Bionics LLC, of Manchester, New Hampshire, a company created to market the technology
developed by DEKA Integrated Solutions Corp., also of Manchester, under DARPA’s Revolutionizing
Prosthetics program.

The
first production versions of “LUKE” arms, a groundbreaking upper-limb
prostheses, were on display during a ceremony at WalterReedNationalMilitaryMedicalCenter.
The Defense Advanced Research Projects Agency is collaborating with Walter Reed
to make the bionic arms available to service members and veterans who are
rehabilitating after suffering upper-limb loss. (DoD photo)

The prosthetic system allows very
dexterous arm and hand movement with grip force feedback through a simple intuitive
control system, DARPA says.

The modular battery-powered limb is
near-natural size and weight. Its hand has six user-chosen grips and an arm
that allows for simultaneous control of multiple joints using inputs that
include wireless signals generated by innovative sensors worn on a user’s feet.

Revolutionizing Prosthetics

The technology that powers prosthetic
legs has advanced steadily over the past two decades but prosthetic arms and
hands are a tougher challenge, in part because of the need for greater degrees
of dexterity, DARPA says.

When the LUKE arm first went into
development, people who had lost upper limbs had to use a relatively primitive
split-hook device that hadn’t changed much since it was introduced in
1912.

DARPA launched the Revolutionizing
Prosthetics program with a goal of getting U.S. Food and Drug Administration
approval for an advanced electromechanical prosthetic upper limb with
near-natural control that enhances independence and improves quality of life
for amputees. LUKE received FDA approval less than eight years after the effort
began, DARPA says.

Under a recently finalized agreement
between DARPA and Walter Reed, DARPA will transfer LUKE arms from an initial
production run to the medical center for prescription to patients. Mobius
Bionics will train the Walter Reed staff to fit, service and support the
arms.